Patient-Specific Guides vs. Classical Workflow in Class IV Mandibular Fracture Fixation

Mohamed abdelsalam Gaber elkhouly

Status: Not yet enrolling

Conditions: Mandibular Class Iv Fractures

Treatments: Device: 2 titanium per-bent mini plates; Device: patient-specific screw holes locating surgical guide and pre-bent plates

Study type: Interventional

Funder types: Other

Identifiers

NCT07153354

3D-T4F-RCT-2025

Details and patient eligibility

About

This study aims to overcome the limitations of current, standard approach of mandibular fracture reduction and fixation including improper alignment of segments, malocclusion, nerve affections and related teeth roots injury. The introduction of Computer Aided designing/Computer Aided manufacturing software has provided surgeons with an opportunity to perform virtual manipulations of computed tomography datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with delayed mandibular class IV fracture need open reduction and internal fixation.
• Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
• Both genders, males and females, will be included

Exclusion criteria

• General contraindications to surgery.
• Patients with unfavorable or comminuted fractures.
• Subjected to irradiation in the head and neck area less than 1 year before fixation.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Patients participating in other studies, if the present protocol could not be properly followed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

patient-specific screw holes locating surgical guide and pre-bent plates osteosynthesis

Experimental group

Description:

Patients In this group will be reduced using patient computer-guided specific screw holes locating guide and pre-bent plates(2.3 for inferior border and 2.0 for superior border)

Treatment:

Device: patient-specific screw holes locating surgical guide and pre-bent plates

classical work-flow

Active Comparator group

Description:

Patients In this group will be reduced by classical reduction and fixation protocol

Treatment:

Device: 2 titanium per-bent mini plates